Healthy SubjectsPhase 1NCT04255277
To Study the Effect of Cenerimod on the Electrical Activity of the Heart, in Men and Women. To Study the Effect of Cenerimod on the Use of Oral Contraceptives in Women. To Study the Effect That Charcoal Has on the Elimination of Cenerimod From the Body, in Women and Men.
A Phase 1 study testing Combined oral contraceptives (COC), Moxifloxacin 400mg and Cenerimod 0.5 mg in people with Healthy Subjects, run by Viatris Innovation GmbH at 1 site in France.
Trial summary
This is a single-center, randomized, double-blind for cenerimod, open-label for moxifloxacin, placebo- and moxifloxacin-controlled, parallel-group study to investigate the effect of cenerimod on the duration of the QT interval in healthy male and female participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Combined oral contraceptives (COC), Moxifloxacin 400mg and Cenerimod 0.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2020to 18 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
- Body mass index of 18.0 to 29.9 kg/m^2 (inclusive) at the screening.
- No clinically relevant findings on the physical examination at screening.
- Systolic blood pressure 90 to 145 mmHg, diastolic blood pressure 45 to 90 mmHg, and pulse rate 50 to 100 bpm (inclusive), measured on the same arm, after 5 min in the supine position at screening and on Day -1.
- 12-lead ECG without clinically relevant abnormalities, measured after 5 min in the supine position at screening and on admission.
- No clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis) at screening and on admission.
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- Negative results from urine drug screen and breath alcohol tests at screening and on admission.
- Women of non-childbearing potential (i.e., postmenopausal [defined as 12 consecutive months with no menses without an alternative medical cause, confirmed by a follicle-stimulating hormone test], with previous bilateral salpingectomy, bilateral salpingo-oophorectomy or hysterectomy, or with premature ovarian failure [confirmed by a specialist]).
- Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use (from screening, during the entire study, and up to end-of-study) a highly effective method of contraception with a failure rate of less than 1% per year (i.e., intrauterine device, bilateral tubal occlusion) or be sexually inactive, or have a vasectomized partner. Hormonal contraceptive must not be used within 3 months prior to screening until end of study visit.
Who cannot join
- Previous exposure to cenerimod.
- Previous exposure to combined oral contraceptive(s), moxifloxacin, or charcoal within 3 months prior to screening.
- Known hypersensitivity to treatments of the same class as cenerimod, or any of the excipients.
- Known hypersensitivity to combined oral contraceptive(s), moxifloxacin, or charcoal or treatments of the same class, or any of their excipients.
- Any contraindication to combined oral contraceptive(s) or moxifloxacin treatment.
- Known hypersensitivity or allergy to natural rubber latex.
Show all 22Show fewer
- Lymphopenia (< 1000 cells/μL) at Screening and on Day -1.
- Familial history of sick-sinus syndrome.
- Any cardiac condition or illness (including ECG abnormalities) with a potential to increase the cardiac risk of the subject based on the standard 12-lead ECG at screening.
- History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation.
- Clinically relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Any immunosuppressive treatment within 6 weeks or 5 terminal half-lives (t½), whichever is longer, before first study drug administration.
- History or clinical evidence of alcoholism or drug abuse.
- Excessive caffeine consumption, defined as 800 mg or more per day at screening.
- Nicotine consumption within 3 months prior to screening and inability to refrain from nicotine consumption.
- Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals).
- Viral, fungal, bacterial or protozoal infection and / or serology.
- History of deep vein thrombophlebitis or thromboembolic disorders.
- Legal incapacity or limited legal capacity at screening.
- Pregnant or lactating women.
- History or presence of rhythm disorders (e.g., sinoatrial heart block, sick-sinus syndrome, second- or third-degree atrioventricular block, long QT syndrome, symptomatic bradycardia, atrial flutter, or atrial fibrillation) .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Double-blind for Cenerimod, Open-label for Moxifloxacin, Placebo-controlled, Parallel-group, Randomized Study in Healthy Male and Female Subjects to Investigate I: the Effect of Cenerimod on the QTc Interval II: the Effect of Cenerimod on the Pharmacokinetics of Combined Oral Contraceptives III: the Effect of Charcoal on the Pharmacokinetics of Cenerimod.
This is a single-center, randomized, double-blind for cenerimod, open-label for moxifloxacin, placebo- and moxifloxacin-controlled, parallel-group study to investigate the effect of cenerimod on the duration of the QT interval in healthy male and female participants.
Participants will be randomly assigned to one of the 4 treatments: placebo, cenerimod 0.5 mg, cenerimod 4 mg or moxifloxacin.
Read the detailed description
Participants randomized in one of the cenerimod or placebo groups will receive combined oral contraceptives on Day 1 (i.e., prior to cenerimod or placebo administration, Period 1) and on Day 42 (i.e., 36 days after the stat of cenerimod or placebo, Period 2).
Half of the participants randomized in one of the cenerimod or placebo groups will be enrolled in an accelerated elimination procedure part (Period 3).
- Conditions
- Healthy Subjects
- Being tested
- Combined oral contraceptives (COC), Moxifloxacin 400mg, Cenerimod 0.5 mg, Cenerimod 4 mg, Charcoal, activated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined oral contraceptives (COC)Drug
Also called Levonorgestrel/Ethinylestradiol
A commercially available COC consisting of 0.1mg levonorgestrel and 0.02 mg ethinylestradiol will be used and administered open-label.
Moxifloxacin 400mgDrug
A commercially available formulation of moxifloxacin 400 mg will be used and administered open-label. All tablets will be from the same batch.
Cenerimod 0.5 mgDrug
Also called ACT-334441
This will be administered orally as a film-coated tablet in the morning.
Cenerimod 4 mgDrug
Also called ACT-334441
This will be administered orally as a film-coated tablet in the morning.
Charcoal, activatedOther
Also called Carbomix 50g
Granules for oral suspension will be used and administered open-label.
Matching PlaceboDrug
Cenerimod matching placebo tablets will be administered once daily orally in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Period 1: First administration of combined oral contraceptives | Other | Participants randomized to placebo or cenerimod will receive a single oral dose of levonorgestrel (100 μg) and ethinylestradiol (20 μg) in the morning on Day 1. Receives: Drug: Combined oral contraceptives (COC) |
| Period 2: Second administration of Combined Oral Contraceptive | Other | Participants randomized to placebo or cenerimod will receive a single oral dose of levonorgestrel (100 μg) and ethinylestradiol (20 μg) in the morning on Day 42. Receives: Drug: Combined oral contraceptives (COC); Drug: Cenerimod 0.5 mg; Drug: Cenerimod 4 mg |
| Period 2: Cenerimod 0.5 mg | Experimental | Participants randomized to cenerimod 0.5 mg will receive a single oral dose in the morning from Day 7 to Day 56. Receives: Drug: Combined oral contraceptives (COC) |
| Period 2: Cenerimod 4 mg | Experimental | Participants randomized to cenerimod 4 mg will receive a single oral dose in the morning from Day 7 to Day 56. Receives: Drug: Combined oral contraceptives (COC) |
| Period 2: Moxifloxacin | Other | Participants randomized to moxifloxacin will receive a single oral 400 mg dose in the morning of Day 42. Receives: Drug: Moxifloxacin 400mg |
| Period 2: Placebo | Placebo comparator | Participants randomized to placebo will receive a single oral dose of placebo in the morning from Day 7 to Day 56. Receives: Drug: Matching Placebo |
| Period 3: Cenerimod 0.5 mg and charcoal | Experimental | Participants randomized to cenerimod 0.5 mg in Period 2 will receive 50 g of activated charcoal every 12 hours from Day 57 to Day 67. Receives: Drug: Cenerimod 0.5 mg; Other: Charcoal, activated |
| Period 3: Cenerimod 4 mg and charcoal | Experimental | Participants randomized to cenerimod 4 mg in Period 2 will receive 50 g of activated charcoal every 12 hours from Day 57 to Day 67. Receives: Drug: Cenerimod 4 mg; Other: Charcoal, activated |
| Period 3: Cenerimod elimination period | No intervention | Participants randomized to cenerimod 0.5 mg or 4 mg in Period 2 will receive no treatment (i.e., activated charcoal from Day 57 to Day 67) but will have blood samples taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF)
ECG variables will be assessed from ECGs extracted in replicates at predefined time points from continuous 24 hour Holter ECG recordings.
Measured: Day 6, 7, 14, 21, 35, and 56.
Maximum plasma concentration (Cmax): levonorgestrel
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Measured: Day 1 to Day 3; Day 42 to Day 44
Maximum plasma concentration (Cmax): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Measured: Day 1 to Day 3; Day 42 to Day 44
Time to reach Cmax (tmax): levonorgestrel
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Measured: Day 1 to Day 3; Day 42 to Day 44
Time to reach Cmax (tmax): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Measured: Day 1 to Day 3; Day 42 to Day 44
The area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf): levonorgestrel
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Measured: Day 1 to Day 3; Day 42 to Day 44
The area under the plasma concentration-time curve (AUC) from zero to t (AUC0-t): levonorgestrel
Blood samples for determination of PK parameters will be collected at predefined
Measured: Day 1 to Day 3; Day 42 to Day 44
The area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Measured: Day 1 to Day 3; Day 42 to Day 44
The area under the plasma concentration-time curve (AUC) from zero to t (AUC0-t): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Measured: Day 1 to Day 3; Day 42 to Day 44
Terminal elimination half-life (t1/2): levonorgestrel
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Measured: Day 56 to Day 68
Terminal elimination half-life (t1/2): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Measured: Day 56 to Day 68
Terminal elimination half-life (t1/2): cenerimod
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Measured: Day 56 to Day 68
Area under the plasma concentration-time curve (AUC) from Day 56 to infinity (AUC56-inf) for cenerimod
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Measured: Day 56 to Day 68
Secondary outcomes (3)
Change from baseline in total lymphocyte count to each time point
Blood samples (fasting) collected at predefined time points as part of the normal hematology analysis.
Measured: Day 5, Day 7, Day 14, Day 21, Day 35, Day 56, Day 57, Day 58, Day 1, Day 64, and Day 67
Maximum plasma concentration (Cmax): cenerimod
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Measured: Day 7, Day 14, Day 21, Day 35, and Day 56
Time to reach Cmax (tmax): cenerimod
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Measured: Day 7, Day 14, Day 21, Day 35, and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start31 Jan 2020
- Primary completion14 Sep 2021
- Study completion18 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Period 1: Pharmacokinetic study, Period 2: Thorough-QT and Drug-drug-interaction study. Period 3: Accelerated elimination study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viatris Innovation GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Viatris Innovation GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255277
- Sponsor's protocol ID
- ID-064-105
- Other IDs
- 2019-003156-36, 2019
- Status last verified
- Nov 2022
- First submitted
- 29 Jan 2020
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Double-blind for Cenerimod, Open-label for Moxifloxacin, Placebo-controlled, Parallel-group, Randomized Study in Healthy Male and Female Subjects to Investigate I: the Effect of Cenerimod on the QTc Interval II: the Effect of Cenerimod on the Pharmacokinetics of Combined Oral Contraceptives III: the Effect of Charcoal on the Pharmacokinetics of Cenerimod.
- ClinicalTrials.gov ID
- NCT04255277
- Acronym / sponsor ID
- ID-064-105
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Viatris Innovation GmbHIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized, double-blind for cenerimod, open-label for moxifloxacin, placebo- and moxifloxacin-controlled, parallel-group study to investigate the effect of cenerimod on the duration of the QT interval in healthy male and female participants.
Participants will be randomly assigned to one of the 4 treatments: placebo, cenerimod 0.5 mg, cenerimod 4 mg or moxifloxacin.
Detailed description
Participants randomized in one of the cenerimod or placebo groups will receive combined oral contraceptives on Day 1 (i.e., prior to cenerimod or placebo administration, Period 1) and on Day 42 (i.e., 36 days after the stat of cenerimod or placebo, Period 2).
Half of the participants randomized in one of the cenerimod or placebo groups will be enrolled in an accelerated elimination procedure part (Period 3).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
- Model description
- Period 1: Pharmacokinetic study, Period 2: Thorough-QT and Drug-drug-interaction study. Period 3: Accelerated elimination study.
| Arm | Type | Receives |
|---|---|---|
| Period 1: First administration of combined oral contraceptives | Other | Drug: Combined oral contraceptives (COC)Participants randomized to placebo or cenerimod will receive a single oral dose of levonorgestrel (100 μg) and ethinylestradiol (20 μg) in the morning on Day 1. |
| Period 2: Second administration of Combined Oral Contraceptive | Other | Drug: Combined oral contraceptives (COC), Drug: Cenerimod 0.5 mg, Drug: Cenerimod 4 mgParticipants randomized to placebo or cenerimod will receive a single oral dose of levonorgestrel (100 μg) and ethinylestradiol (20 μg) in the morning on Day 42. |
| Period 2: Cenerimod 0.5 mg | Experimental | Drug: Combined oral contraceptives (COC)Participants randomized to cenerimod 0.5 mg will receive a single oral dose in the morning from Day 7 to Day 56. |
| Period 2: Cenerimod 4 mg | Experimental | Drug: Combined oral contraceptives (COC)Participants randomized to cenerimod 4 mg will receive a single oral dose in the morning from Day 7 to Day 56. |
| Period 2: Moxifloxacin | Other | Drug: Moxifloxacin 400mgParticipants randomized to moxifloxacin will receive a single oral 400 mg dose in the morning of Day 42. |
| Period 2: Placebo | Placebo comparator | Drug: Matching PlaceboParticipants randomized to placebo will receive a single oral dose of placebo in the morning from Day 7 to Day 56. |
| Period 3: Cenerimod 0.5 mg and charcoal | Experimental | Drug: Cenerimod 0.5 mg, Other: Charcoal, activatedParticipants randomized to cenerimod 0.5 mg in Period 2 will receive 50 g of activated charcoal every 12 hours from Day 57 to Day 67. |
| Period 3: Cenerimod 4 mg and charcoal | Experimental | Drug: Cenerimod 4 mg, Other: Charcoal, activatedParticipants randomized to cenerimod 4 mg in Period 2 will receive 50 g of activated charcoal every 12 hours from Day 57 to Day 67. |
| Period 3: Cenerimod elimination period | No intervention | –Participants randomized to cenerimod 0.5 mg or 4 mg in Period 2 will receive no treatment (i.e., activated charcoal from Day 57 to Day 67) but will have blood samples taken. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
- Body mass index of 18.0 to 29.9 kg/m^2 (inclusive) at the screening.
- No clinically relevant findings on the physical examination at screening.
- Systolic blood pressure 90 to 145 mmHg, diastolic blood pressure 45 to 90 mmHg, and pulse rate 50 to 100 bpm (inclusive), measured on the same arm, after 5 min in the supine position at screening and on Day -1.
- 12-lead ECG without clinically relevant abnormalities, measured after 5 min in the supine position at screening and on admission.
Key exclusion criteria (22 listed)
- Previous exposure to cenerimod.
- Previous exposure to combined oral contraceptive(s), moxifloxacin, or charcoal within 3 months prior to screening.
- Known hypersensitivity to treatments of the same class as cenerimod, or any of the excipients.
- Known hypersensitivity to combined oral contraceptive(s), moxifloxacin, or charcoal or treatments of the same class, or any of their excipients.
- Any contraindication to combined oral contraceptive(s) or moxifloxacin treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined oral contraceptives (COC)Also: Levonorgestrel/EthinylestradiolA commercially available COC consisting of 0.1mg levonorgestrel and 0.02 mg ethinylestradiol will be used and administered open-label. | Drug | Period 1: First administration of combined oral contraceptives, Period 2: Cenerimod 0.5 mg, Period 2: Cenerimod 4 mg, Period 2: Second administration of Combined Oral Contraceptive |
| Moxifloxacin 400mgA commercially available formulation of moxifloxacin 400 mg will be used and administered open-label. All tablets will be from the same batch. | Drug | Period 2: Moxifloxacin |
| Cenerimod 0.5 mgAlso: ACT-334441This will be administered orally as a film-coated tablet in the morning. | Drug | Period 2: Second administration of Combined Oral Contraceptive, Period 3: Cenerimod 0.5 mg and charcoal |
| Cenerimod 4 mgAlso: ACT-334441This will be administered orally as a film-coated tablet in the morning. | Drug | Period 2: Second administration of Combined Oral Contraceptive, Period 3: Cenerimod 4 mg and charcoal |
| Charcoal, activatedAlso: Carbomix 50gGranules for oral suspension will be used and administered open-label. | Other | Period 3: Cenerimod 0.5 mg and charcoal, Period 3: Cenerimod 4 mg and charcoal |
| Matching PlaceboCenerimod matching placebo tablets will be administered once daily orally in the morning. | Drug | Period 2: Placebo |
Primary outcome
Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF)
Time frame: Day 6, 7, 14, 21, 35, and 56.
ECG variables will be assessed from ECGs extracted in replicates at predefined time points from continuous 24 hour Holter ECG recordings.
Maximum plasma concentration (Cmax): levonorgestrel
Time frame: Day 1 to Day 3; Day 42 to Day 44
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Maximum plasma concentration (Cmax): ethinylestradiol
Time frame: Day 1 to Day 3; Day 42 to Day 44
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time to reach Cmax (tmax): levonorgestrel
Time frame: Day 1 to Day 3; Day 42 to Day 44
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time to reach Cmax (tmax): ethinylestradiol
Time frame: Day 1 to Day 3; Day 42 to Day 44
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
The area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf): levonorgestrel
Time frame: Day 1 to Day 3; Day 42 to Day 44
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
The area under the plasma concentration-time curve (AUC) from zero to t (AUC0-t): levonorgestrel
Time frame: Day 1 to Day 3; Day 42 to Day 44
Blood samples for determination of PK parameters will be collected at predefined
The area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf): ethinylestradiol
Time frame: Day 1 to Day 3; Day 42 to Day 44
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
The area under the plasma concentration-time curve (AUC) from zero to t (AUC0-t): ethinylestradiol
Time frame: Day 1 to Day 3; Day 42 to Day 44
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Terminal elimination half-life (t1/2): levonorgestrel
Time frame: Day 56 to Day 68
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Terminal elimination half-life (t1/2): ethinylestradiol
Time frame: Day 56 to Day 68
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Terminal elimination half-life (t1/2): cenerimod
Time frame: Day 56 to Day 68
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Area under the plasma concentration-time curve (AUC) from Day 56 to infinity (AUC56-inf) for cenerimod
Time frame: Day 56 to Day 68
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
3 secondary outcomes
Change from baseline in total lymphocyte count to each time point
Time frame: Day 5, Day 7, Day 14, Day 21, Day 35, Day 56, Day 57, Day 58, Day 1, Day 64, and Day 67
Maximum plasma concentration (Cmax): cenerimod
Time frame: Day 7, Day 14, Day 21, Day 35, and Day 56
Time to reach Cmax (tmax): cenerimod
Time frame: Day 7, Day 14, Day 21, Day 35, and Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Viatris Innovation GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combined oral contraceptives (COC), Moxifloxacin 400mg and Cenerimod 0.5 mg in people with Healthy Subjects, run by Viatris Innovation GmbH at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF) (time frame: Day 6, 7, 14, 21, 35, and 56.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.